AMGN's Eczema Drug Meets Goal in Two Late-Stage Studies

Amgen AMGN announced positive results from two clinical studies, IGNITE and SHUTTLE, which are part of the phase III ROCKET program that is evaluating the investigational anti-OX40 therapy rocatinlimab for atopic dermatitis (AD or eczema) indication in adults.

While the IGNITE study evaluated rocatinlimab as monotherapy for 24 weeks, the SHUTTLE study evaluated the drug in combination with topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) over the same timeframe. Both studies met their primary and key secondary endpoints.

More on AMGN’s IGNITE Study Results

The IGNITE study evaluated two dose levels of the drug — high and low. Treatment with both these dose levels met the study’s co-primary endpoints of EASI-75 (at least 75% reduction in disease severity) and validated Investigator's Global Assessment for Atopic Dermatitis (or, vIGA-AD, to evaluate the overall severity of the disease).

In the high-dose group, 42.3% of patients achieved EASI-75 (at least 75% reduction in disease severity), with a placebo-adjusted difference of 29.5%. In the lower-dose group, 36.3% of patients reached EASI-75, showing a placebo-adjusted improvement of 23.4%.

At week 24, 23.6% of patients in the high-dose group achieved a vIGA-AD score of zero (clear) or one (almost clear) with at least a two-point reduction from baseline — a 14.9% improvement over placebo. In the lower-dose group, 19.1% of patients met this endpoint, with a placebo-adjusted difference of 10.3%.

According to some investors, the results were better than those from the phase III HORIZON study, also part of the ROCKET program, reported last September. The study showed that 32.8% of patients treated with rocatinlimab achieved EASI-75 compared to 13.7% in the placebo group. However, several Wall Street analysts compared the results to Sanofi SNY/Regeneron’s REGN blockbuster immunology drug Dupixent, which is also considered the standard of care in AD indication.

In two late-stage studies that supported the FDA’s approval of Dupixent in AD, 51% and 44% of people taking the SNY-REGN-partnered drug achieved EASI-75 compared with 15% and 12%, respectively, in the placebo arm. Based on this comparison, Wall Street had called the HORIZON study results ‘modest’ or ‘below expectations’.

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More on AMGN’s SHUTTLE Study

The SHUTTLE study has the same co-primary endpoints as the IGNITE study. In the high-dose group, 52.3% of patients achieved EASI-75, with a placebo-adjusted difference of 28.7%. In the lower-dose group, 54.1% of patients reached EASI-75, showing a placebo-adjusted improvement of 30.4%.

For the vIGA-AD endpoint, 26.1% of patients in the high-dose group achieved a score of zero or one — a 13.8% improvement over placebo. In the lower-dose group, 25.8% of patients met this endpoint, with a placebo-adjusted difference of 13.5%.

The HORIZON, IGNITE and SHUTTLE studies are three of the eight studies in the ROCKET program evaluating rocatinlimab in AD indication. Though Amgen did not report data from the VOYAGER study, it did mention that the study ‘successfully’ showed that the drug ‘did not interfere with responses to tetanus and meningococcal vaccinations’.

Apart from the above studies, Amgen is also evaluating the drug in adolescents for 24 weeks in two separate phase III studies, ASTRO and ORBIT, which are also part of the ROCKET program. The company is conducting the phase III ASCEND study, evaluating rocatinlimab in adults and adolescents beyond 24 weeks. Data readouts from these studies are expected later this year.

Amgen, along with Japan-based Kyowa Kirin, is developing rocatinlimab, as part of a collaboration deal signed in 2021. AMGN made an upfront payment of $400 million to Kyowa. Apart from eczema, the companies are also developing the drug for prurigo nodularis (phase III) and asthma (phase II).

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